Transcatheter guidewire delivery systems, catheter assemblies for guidewire delivery, and methods for percutaneous guidewire delivery across heart valves

ABSTRACT

Transcatheter guidewire delivery systems, catheter assemblies and associated methods for percutaneous guidewire delivery across heart valves are disclosed herein. A catheter assembly configured in accordance herewith includes an elongated tubular component and an alignment assembly at a distal portion of the tubular component and which is adapted to be located at a target location adjacent a heart valve of a patient. In one embodiment, the alignment assembly deploys to a shape set loop configuration with a side port in an open configuration positioned to allow advancement of a guidewire to exit the catheter in an aligned path with a leaflet coaptation region of the heart valve. In another embodiment, the alignment assembly has a plurality of spaced apart side ports that a guidewire may advance therethrough and toward the heart valve. In some embodiments, a wire guide is used to align the guidewire with a selected side port.

FIELD OF THE INVENTION

The present technology relates generally to intravascular delivery ofguidewires across a heart valve, catheter assemblies for guidewiredelivery and associated methods. In particular, several embodiments aredirected to catheter assemblies having alignment features for directingguidewires across heart valves, such as an aortic valve.

BACKGROUND OF THE INVENTION

The human heart is a four chambered, muscular organ that provides bloodcirculation through the body during a cardiac cycle. The four mainchambers include the right atria and right ventricle which supplies thepulmonary circulation, and the left atria and left ventricle whichsupplies oxygenated blood received from the lungs to the remaining body.To insure that blood flows in one direction through the heart,atrioventricular valves (tricuspid and mitral valves) are presentbetween the junctions of the atria and the ventricles, and semi-lunarvalves (pulmonary valve and aortic valve) govern the exits of theventricles leading to the lungs and the rest of the body. These valvescontain leaflets or cusps that open and shut in response to bloodpressure changes caused by the contraction and relaxation of the heartchambers. The leaflets move apart from each other to open and allowblood to flow downstream of the valve, and coapt to close and preventbackflow or regurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by damage ora defect, can include stenosis and valvular insufficiency orregurgitation. For example, valvular stenosis causes the valve to becomenarrowed and hardened which can prevent blood flow to a downstream heartchamber or structure (e.g., aorta) to occur at the proper flow rate andcause the heart to work harder to pump the blood through the diseasedvalve. Aortic stenosis, for example, can lead to chest pain, fainting,and heart failure. Valvular insufficiency or regurgitation occurs whenthe valve does not close completely, allowing blood to flow backwards,thereby causing the heart to be less efficient. For example, aorticvalvular insufficiency results in blood pooling in the left ventriclewhich must then expand its normal capacity to accommodate the pooledvolume of blood as well as the new blood received in the subsequentcardiac cycle. For this reason the heart muscle must work harder to pumpthe extra volume of blood which causes strain of the heart muscle overtime as well as raises the blood pressure in the heart. A diseased ordamaged valve, which can be congenital, age-related, drug-induced, or insome instances, caused by infection, can result in an enlarged,thickened heart that loses elasticity and efficiency. Other symptoms ofheart valve diseases, such as stenosis and valvular insufficiency, caninclude weakness, shortness of breath, dizziness, fainting,palpitations, anemia and edema, and blood clots which can increase thelikelihood of stroke or pulmonary embolism. Such symptoms can often besevere enough to be debilitating and/or life threatening.

Surgical strategies for repairing and/or replacing diseased or damagedheart valves can include percutaneously delivering interventional toolsand/or prosthetic heart valve devices through catheter-based systems.Before delivering such tools and prosthetic devices, a guidewire may beused to introduce a delivery catheter and subsequently deliveredprosthetic devices and/or tools into the proper position (e.g., withinthe aortic valve). For example, the delivery catheter may be introducedusing a surgical cut down or Seldinger access to the femoral artery inthe patient's groin. Once a guidewire is properly placed across thetargeted heart valve, the delivery catheter may be introduced over theguidewire to the desired position using over-the-wire (“OTW”) or rapidexchange (“RX”) techniques. Spanning or crossing native heart valves,such as the aortic valve, with percutaneously placed guidewires canpresent numerous challenges due to differing anatomies and etiologiespresented by individual patients. The varying shapes, sizes and otherfeatures associated with an abnormal or unhealthy aortic valve can makeproper alignment of the guidewire difficult, especially in calcifiedvalves which have a narrower opening during systole. In addition tobeing time consuming, such difficulties can result, in some instances,in cardiac tissue perforation by the guidewire, left bundle branch blockand emboli dislodgement of calcium deposits at the aortic valve.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof are directed to catheter assemblies for deliveringguidewires across a heart valve and methods for percutaneous guidewiredelivery across heart valves, such as the aortic valve. The cathetersand catheter assemblies have a compressed configuration for delivery viaa vasculature or other body lumens to a native heart valve of a patientand have alignment features for stabilizing and aligning guidewires tobe advanced across the targeted heart valves. In an embodiment, acatheter for crossing an aortic valve with a guidewire can include atubular component having a proximal segment and a distal segment,wherein, in a deployed configuration, at least a portion of the distalsegment has a loop configuration. The tubular component may also includea distal opening at a distal end of the distal segment, wherein thedistal opening is configured to receive a guidewire therethrough, andinclude a proximal opening at a proximal end of the proximal segment,wherein the proximal opening is configured to receive a guidewiretherethrough. The tubular component may further include a side portdisposed along the distal segment proximal of the distal opening. Insome arrangements, the distal segment, when in a delivery configuration,is conformable to a guidewire when the guidewire is disposed thereinbetween the side port and distal opening. In one embodiment, retractinga guidewire proximal of the side port can cause the distal segment totransition between the delivery configuration and the deployedconfiguration. When in the deployed configuration, the side port can bein an open configuration such that a guidewire will exit the side port.

In another embodiment, a catheter apparatus may include an elongatedtubular component having a proximal segment and a distal segment. Thecatheter apparatus may also include an alignment assembly having a loopshape in a distal portion of the distal segment of the elongated tubularcomponent and which is adapted to be located at a target locationadjacent a heart valve of a human patient. In certain arrangements, theelongated tubular component and the alignment assembly together definetherethrough a guidewire lumen configured to slidably receive a medicalguidewire, wherein axial movement of the guidewire relative to thealignment assembly can transform the alignment assembly between (a) alow-profile delivery configuration and (b) a deployed configurationtending to assume the loop shape of the alignment assembly. When in thedeployed configuration, the alignment assembly can have a side port inan open configuration and positioned to allow a subsequent advancementof the guidewire to exit the side port in a non-axial direction relativeto the guidewire lumen.

In yet another aspect, embodiments of the present technology provide amethod of crossing an aortic valve with a guidewire. In one embodiment,the method can include advancing a catheter and a first guidewirethrough the vasculature of a patient to a location downstream of theaortic valve, wherein the first guidewire is disposed in a proximalsegment and a distal segment of the catheter such that the catheterconforms to the shape of the first guidewire. The method may alsoinclude retracting the first guidewire proximal of the distal segment ofthe catheter, wherein retraction of the first guidewire can cause atleast a portion of the distal segment of the catheter to deploy to aloop configuration to support the distal segment of the catheter againstwalls of a vessel adjacent to the aortic valve. The method may furtherinclude advancing a second guidewire distally such that the secondguidewire exits a side port proximal of a distal end of the catheter,wherein the side port is faced towards the leaflets of the aortic valveto direct the second guidewire thereto.

In additional embodiments, a catheter assembly for crossing a heartvalve with a guidewire may include a tubular support structure adaptedto be located at a target location adjacent to the heart valve of ahuman patient. In certain embodiments, the support structure may includea proximal segment having a proximal opening at a proximal end, a distalsegment having a distal opening at a distal end, and a plurality ofspaced-apart side ports disposed proximal to the distal opening. Theproximal segment and the distal segment together may define therethrougha guidewire lumen configured to slidably receive a first guidewire. Thecatheter assembly may also include a wire guide slidably disposed withinthe support structure. In various arrangements, the wire guide may havea lumen for slidably receiving a second guidewire through a proximalguidewire port disposed within a first portion and transmitting thesecond guidewire through a distal guidewire port disposed within asecond portion. In one embodiment, axial movement of the wire guiderelative to the support structure can align the distal guidewire port ofthe wire guide with one of the plurality of spaced-apart side ports,such that in a subsequent advancement of the second guidewire, thesecond guidewire can exit the aligned side port.

Additional aspects of the present technology may also be directed tocatheter systems for aligning a therapeutic tool relative to ananatomical feature in a body lumen of a patient. In one embodiment, asystem can include a tubular component and an alignment assemblydisposed at a distal portion of the tubular component. The alignmentassembly may be adapted to be located at a target location within thebody lumen of the patient. Additionally, the alignment assembly can havean outer body and a lumen therethrough, and wherein the alignmentassembly has a plurality of spaced-apart side ports. The system may alsoinclude a tool guide slidably disposed within the tubular structure andthe alignment assembly. In some arrangements, the tool guide can have aninternal lumen for providing a path for the therapeutic tool between aproximal opening and a distal opening. The system may further have analignment guide disposed on an outer surface of the tool guide at aproximal portion adapted to remain outside the body of the patient. Thealignment guide, in some embodiments, may provide a visualrepresentation of the position of the distal opening relative to theplurality of spaced-apart side ports on the alignment assembly.

In a further aspect, embodiments of the present technology may provideanother method of crossing an aortic valve with a guidewire. In oneembodiment, the method can include advancing a support structure and afirst guidewire through the vasculature of a patient to a locationdownstream of the aortic valve, wherein the first guidewire is disposedin a proximal segment and a distal segment of the support structure. Themethod may also include axially sliding a wire guide within the supportstructure such that a distal opening of the wire guide is axiallyaligned with one of a plurality of side ports disposed in the distalsegment of the support structure. The method may further includeadvancing a second guidewire distally through the wire guide such thatthe second guidewire exits the aligned side port of the supportstructure towards the leaflets of the aortic valve.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and aspects of the present technologycan be better understood from the following description of embodimentsand as illustrated in the accompanying drawings. The accompanyingdrawings, which are incorporated herein and form a part of thespecification, further serve to illustrate the principles of the presenttechnology. The components in the drawings are not necessarily to scale.

FIG. 1 is a schematic sectional illustration of a mammalian heart havingnative valve structures.

FIG. 2A is a schematic illustration of an inferior view of a healthyaortic valve isolated from the surrounding heart structures and showingthe annulus and native leaflets.

FIG. 2B is a schematic illustration of an inferior view of a stenotic ordiseased aortic valve isolated from the surrounding heart structures andshowing the annulus and native leaflets.

FIG. 3A is a side view of a minimally invasive catheter apparatusconfigured in accordance with an embodiment hereof.

FIG. 3B is a partial side view of a minimally invasive catheterapparatus configured in accordance with another embodiment hereof.

FIG. 4A is an enlarged sectional view of a distal segment of a catheterwith an intravascular alignment assembly in a delivery state (e.g.,low-profile or collapsed configuration) in accordance with an embodimenthereof.

FIG. 4B is a side view of the distal segment of the catheter of FIG. 4Ashowing the alignment assembly in a deployed state (e.g., expandedconfiguration) in accordance with an embodiment hereof.

FIG. 4C is a transverse end view of the alignment assembly shown in thedirection of the arrow 4C of FIG. 4B.

FIG. 4D illustrates a cut-away view of an aorta and aortic valve of apatient and showing a partial side view of the intravascular alignmentassembly of FIGS. 4A-4C having a loop-shaped configuration in a deployedstate (e.g., expanded configuration) in accordance with a furtherembodiment hereof.

FIGS. 5A-5C are partial side views of the catheter of FIGS. 4A-4Dshowing the alignment assembly deployed within the aorta A of a patientand illustrating steps in a method for adjusting a guidewire paththrough a loop shape thereof and across the aortic valve in accordancewith an embodiment hereof.

FIG. 6A is a flow diagram illustrating a method for crossing an aorticvalve with a guidewire in a patient using the catheter of FIG. 4A and inaccordance with an embodiment hereof.

FIG. 6B is a flow diagram illustrating another method for crossing theaortic valve with a guidewire in a patient using the catheter of FIG. 4Aand in accordance with an embodiment hereof.

FIG. 7A is an enlarged sectional view of a distal segment of a catheterwith an intravascular alignment assembly in a delivery state (e.g.,low-profile or collapsed configuration) in accordance with anotherembodiment hereof.

FIG. 7B illustrates a cut-away view of an aorta and aortic valve of apatient and showing a partial side view of the distal segment of thecatheter of 7A and showing the alignment assembly in a deployed state(e.g., an expanded configuration) in accordance with an embodimenthereof.

FIG. 8 is a perspective view of a distal segment of a catheter with anintravascular alignment assembly in a deployed state (e.g., an expandedconfiguration) adjacent an aortic valve in a patient in accordance witha further embodiment hereof.

FIG. 9A is an exploded view of a distal segment of a catheter assemblyin accordance with another embodiment hereof.

FIG. 9B is an enlarged sectional view of the distal segment of thecatheter shown in FIG. 9A in accordance with an embodiment hereof.

FIG. 10 is a perspective view of the distal segment of the catheterassembly of FIG. 9A within an aorta and adjacent to the aortic valve ofa patient in accordance with a further embodiment hereof.

FIG. 11 is an enlarged sectional view of a distal portion of a wireguide with a deflector for directing a guidewire through a distalguidewire port at a deflection angle in accordance with an embodimenthereof.

FIGS. 12A and 12B are an enlarged planar side views of the catheterassembly of FIG. 9A showing a guidewire exiting an aligned side port atvarious rotation angles in accordance with an embodiment hereof.

FIG. 13 is a perspective view of the catheter assembly shown in FIG. 9Aillustrating an alignment guide disposed on a first portion of the wireguide in accordance with another embodiment hereof.

FIG. 14A is a flow diagram illustrating a method for crossing an aorticvalve with a guidewire in a patient using the catheter of FIG. 9A and inaccordance with an embodiment hereof.

FIG. 14B is a flow diagram illustrating another method for crossing theaortic valve with a guidewire in a patient using the catheter of FIG. 9Aand in accordance with an embodiment hereof.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present technology are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal” are used in the following description with respect to aposition or direction relative to the treating clinician or with respectto a catheter or catheter assembly. For example, “distal” or “distally”are a position distant from or in a direction away from the clinicianwhen referring to delivery procedures or along a vasculature. Likewise,“proximal” and “proximally” are a position near or in a direction towardthe clinician.

The following detailed description is merely exemplary in nature and isnot intended to limit the present technology or the application and usesof the present technology. Although the description of embodimentshereof are in the context of treatment of heart valves and particularlyin the context of gaining percutaneous access to an aortic valve, thepresent technology may also be used in any other body passageways whereit is deemed useful. Furthermore, there is no intention to be bound byany expressed or implied theory presented in the preceding technicalfield, background, brief summary or the following detailed description.

Embodiments of the present technology as described herein can becombined in many ways to treat or access one or more of many valves ofthe body including valves of the heart such as the aortic valve. Theembodiments of the present technology can be therapeutically combinedwith many known surgeries and procedures, for example, such embodimentscan be combined with known methods of accessing the valves of the heartsuch as the aortic valve with retrograde approaches, antegradeapproaches, and combinations thereof.

FIG. 1 is a schematic sectional illustration of a mammalian heart 10that depicts the four heart chambers (right atria RA, right ventricleRV, left atria LA, left ventricle LV) and native valve structures(tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valveAV). FIG. 2A is a schematic illustration of an inferior view of ahealthy aortic valve isolated from the surrounding heart structures andshowing the annulus AN and native cusps or leaflets. Referring to FIGS.1 and 2A together, the heart 10 comprises the left atrium LA thatreceives oxygenated blood from the lungs via the pulmonary veins. Theleft atrium LA pumps the oxygenated blood through the mitral valve MVand into the left ventricle LV during ventricular diastole. The leftventricle LV contracts during systole and blood flows outwardly throughthe aortic valve AV, into the aorta and to the remainder of the body.

In a healthy heart, the cusps (e.g., leaflets) of the aortic valve AVmeet evenly at the free edges or “coapt” to close (FIG. 2A) and preventback flow of blood from the aorta. Referring to FIG. 2A, the right cuspRC, the left cusp LC and the posterior cusp PC attach to the surroundingwall of the aorta at the sinotubular junction STJ above a fibrous ringof connective tissue called an annulus AN (FIG. 1). The flexible tissueof the aortic cusps (individually identified as RC, LC, and PC) openfreely during left ventricle LV contraction to allow the blood to leavethe heart chamber and be distributed systemically to the body's tissues.In a heart 10 having aortic valve stenosis, the aortic valve AV hasnarrowed causing the cusps (RC, LC, PC) to not sufficiently coapt ormeet thereby forming a gap 12, as shown in FIG. 2B, that allows blood toback flow into the left ventricle LV. As such, aortic stenosis oftenresults in a heart murmur that can be assessed by ultrasound. Typically,stenosis of the aortic valve AV prevents the valve from openingproperly, forcing the heart muscle to work harder to pump blood throughthe valve. This can cause a pooling of blood and a pressure build-up inthe left ventricle LV, which can thicken the heart muscle. One cause ofvalve stenosis includes progressive calcification of the valve (e.g.,the aortic valve) which causes thickening and hardening of the tissue,and which can challenge crossing the valve with a guidewire forsubsequent delivery of surgical tools and replacement prosthetic valves.Other causes of stenosis can include congenital defects (e.g., bicuspidvalve), results of infections such as rheumatic fever or endocarditis,and age-related hardening of valve tissues.

Embodiments of catheter assemblies, delivery systems and associatedmethods in accordance with the present technology are described in thissection with reference to FIGS. 3-14B. It will be appreciated thatspecific elements, substructures, uses, advantages, and/or other aspectsof the embodiments described herein and with reference to FIGS. 3-14Bcan be suitably interchanged, substituted or otherwise configured withone another in accordance with additional embodiments of the presenttechnology.

Provided herein are systems, devices and methods suitable forintravascular delivery of guidewires across a heart valve in a heart ofa patient. In some embodiments, catheter assemblies and methods arepresented for the treatment of valve disease as part of procedure stepsfor minimally invasive implantation of an artificial or prosthetic heartvalve. For example, a catheter assembly, in accordance with embodimentsdescribed herein, can be used to direct and deliver a medical guidewireacross a diseased or damaged native aortic valve or prior implantedprosthetic aortic valve in a patient, such as in a patient sufferingfrom aortic valve stenosis illustrated in FIG. 2B. In furtherembodiments, the catheter assemblies and guidewire delivery systemsdisclosed herein are suitable for guidewire delivery across otherdiseased or damaged heart valves or prior implanted prosthetic heartvalves, such as tricuspid, pulmonary and mitral heart valves.

FIG. 3A is a side view of a minimally invasive catheter apparatus 100(“catheter 100”) configured in accordance with an embodiment hereof. Thecatheter 100 may be used to align and deliver a medical guidewire 102across a heart valve of a patient. As shown in FIG. 3A, the catheter 100includes a handle 104 operatively coupled to an elongated tubularcomponent 110 or shaft at a proximal end 111 of a proximal segment 112of the tubular component 110. The catheter 100 further includes analignment assembly 120 in a distal segment 114 of the tubular component110 for directing a guidewire (e.g., guidewire 102) across a heart valvein a manner that aligns the guidewire with the coaptation region of theleaflets during systole. The tubular component 110 can have a generallyhollow body that extends between the handle 104 at the proximal end 111to the alignment assembly 120 in the distal segment 114. Together, thetubular component 110 and the alignment assembly 120 define therethrougha lumen 128 configured to slidably receive one or more guidewires (e.g.,guidewire 102 or other guidewire) for delivering the alignment assembly120 adjacent the heart valve and/or crossing the heart valve in anatraumatic manner. In the over-the-wire (“OTW”) embodiment shown in FIG.3A, a proximal end of the guidewire 102 extends from a handle port 106in the handle 104.

As explained in further detail below, and in certain embodiments, thealignment assembly 120 can have a loop configuration (not shown) atleast partially defined by an outer support structure 124, and at leastone side port 122 disposed through the outer support structure 124proximal of a distal end 113 of the alignment assembly 120, which can,in some embodiments, also be the distal end of the tubular component110. In these embodiments, the alignment assembly 120 is configurableinto a delivery state having a low-profile, or substantiallystraightened configuration for advancement of the alignment assembly 120through the vasculature, for instance, to a target location adjacent anaortic valve of a patient. Upon delivery to the target location adjacentthe aortic valve (e.g., downstream of the aortic valve), and at leastpartial retraction of the guidewire 102, the alignment assembly 120 isfurther configurable into a deployed state (not shown) having anexpanded configuration (e.g., a loop-shaped configuration, alasso-shaped configuration, a helical/spiral configuration) for engagingthe internal walls of the aorta downstream of the aortic valve and/or atleast partially resting on the cusps of the aortic valve (e.g., forstabilizing the alignment assembly 120). In the deployed state, thealignment assembly 120 provides a guidewire path through the side port122 in a non-axial or transverse direction relative to the longitudinalor central axis L_(A) of the lumen 128 of the tubular component 110.Further, the non-axial direction of the provided guidewire path can beadjusted to selectively align with a target region such as, for example,a region of leaflet coaptation of the aortic valve. Alternatively, thealignment assembly 120 may not assume a loop shape in the deployed stateprovided that the alignment assembly 120 is in another pre-shapedarrangement that provides a subsequently advanced guidewire an alignedpath from the side port 122 across the aortic valve.

As explained in greater detail below, the alignment assembly 120 can beconfigured to be delivered intravascularly to a target heart valve(e.g., an aortic valve) of a human patient in the delivery state havinga low-profile or substantially straightened configuration. Upon deliveryto the target treatment site, the alignment assembly 120, in accordancewith some embodiments, is further configured to be transformed into thedeployed state having an expanded configuration (e.g., the distalportion of the tubular component 110 is expanded into a loop, lassoand/or spiral configuration). The alignment assembly 120 may betransformed between the delivery and deployed states using a variety ofsuitable mechanisms or techniques (e.g., self-expansion). In anembodiment, the alignment assembly 120 may be the distal segment 114 ofthe tubular component 110 that has a self-expanding tubular structure totransform into the deployed state when unrestricted (e.g., by retractinga guidewire, a guide catheter, straightening sheath, etc.). In anotherembodiment, the alignment assembly 120 may be a separate, self-expandingtubular structure coupled to the tubular component 110. In otherembodiments, the alignment assembly 120 may be placed or transformedinto the deployed state via remote actuation, e.g., via an actuator 108,such as a knob, pin, or lever carried by the handle 104. In otherembodiments, however, the alignment assembly 120 may be transformedbetween the delivery and deployed states using other suitable mechanismsor techniques.

FIG. 3B is a partial side view of a minimally invasive catheter 100Aconfigured in accordance with another embodiment hereof. The catheter100A includes several similar features to the catheter 100. For example,the catheter 100A includes an alignment assembly 120A in a distalsegment 114A of an elongated tubular component 110A or hollow shaft fordirecting a guidewire (e.g., guidewire 102) across a heart valve in anatraumatic manner and/or in a manner that substantially aligns theguidewire with the coaptation region of the leaflets during systole. Inthe embodiment shown in FIG. 3B, the alignment assembly 120A includes anouter support structure 124A having a plurality of side ports 122 a-122d spaced-apart along the distal segment 114A of the tubular component110A. In these embodiments, the tubular component 110A and the alignmentassembly 120A can define one or more lumens, such as lumens 328 a, 328 bas described below with reference to FIG. 7A, configured to receive afirst guidewire (e.g., guidewire 102) therethrough for positioning thealignment assembly 120A at a target location adjacent an aortic valve ofa patient. Upon delivery to the target location adjacent the aorticvalve (e.g., downstream of the aortic valve), the alignment assembly120A provides a guidewire path through a selected side port (e.g., anyone of side ports 122 a-122 d) through which a subsequently advancedsecond guidewire (not shown) exits the selected side port in a non-axialor transverse direction relative to the longitudinal axis L_(A) of thelumen (not shown) to cross the aortic valve.

Referring to FIGS. 3A and 3B together, the catheter 100, 100A may alsoinclude an atraumatic tip 130, 130A at the distal end 113, 113A of thetubular component 110, 110A and/or alignment assembly 120, 120A toprevent intravascular trauma during delivery of the alignment assembly120, 120A to the aortic valve. The distal end 113, 113A of the alignmentassembly 120, 120A and/or tubular component 110, 110A may also beconfigured to engage another element of the catheter 100, 100A. Forexample, the distal end 113, 113A of the alignment assembly 120, 120Amay define a distal opening 118, 118A for receiving the guidewire 102for delivery of the catheter 100, 100A using OTW or rapid exchange(“RX”) techniques. In additional embodiments, the atraumatic tip 130,130A or other features associated with the tubular component 110, 110Aand/or alignment assembly 120, 120A (e.g., any one of side ports 122 or122 a-122 d) can include radiopaque markers and/or be formed ofradiopaque materials (e.g., barium sulfate, bismuth trioxide, bismuthsubcarbonate, powdered tungsten, powdered tantalum, or variousformulations of certain metals, including gold and platinum) that arecapable of being fluoroscopically imaged to allow a clinician todetermine if the alignment assembly 120, 120A is appropriately placedand/or deployed adjacent the aortic valve.

In several embodiments, the catheter 100 can be configured to allowlocational adjustment of the direction and projected path a guidewiretravels for crossing an aortic valve or other heart valve. For example,the catheter 100 can be pulled and pushed at a proximal segment 112allowing fine control over the guidewire path as the guidewire exits aside port of the alignment assembly 120 (by example, the catheter 100shown in FIG. 3A). In other embodiments (by example, the catheter 100Ashown in FIG. 3B), a side port can be selected from a plurality of sideports 122 a-122 d such that a guidewire may traverse the side port andapproach the valve structure in an atraumatic manner (e.g., withoutunintentional damage to the aortic valve). Accordingly, the cathetersand methods described can also provide a physician or operator withimproved control and placement of the guidewire during delivery acrossthe aortic valve. Further details regarding such arrangements aredescribed below with reference to FIGS. 4A-14B.

Following delivery and placement of a guidewire across a desired valvelocation, the catheter 100, 100A with alignment assembly 120, 120A andremaining guidewire (if any) can be removed from the heart and out ofthe body of the patient. Once percutaneous access is achieved,interventional tools, including a prosthetic heart valve, and supportingcatheter(s) may be advanced to the heart intravascularly and positionedadjacent the target cardiac valve in a variety of manners, as describedand known in the art. For example, once the guidewire is positioned, theendoluminal entry port is dilated to permit entry of a delivery catheterthrough the vasculature and along the guidewire path. In some instances,a protective sheath may be advanced to protect the vascular structure.

Selected Embodiments of Catheters Having Shape Set Loop Configurations

FIG. 4A is an enlarged, longitudinal cross-sectional view of a distalsegment 214 of an elongated shaft or tubular component 210 of a catheter200 having an intravascular alignment assembly 220 in a delivery state(e.g., a low-profile, substantially straightened or collapsedconfiguration) and in accordance with an embodiment of the presenttechnology, and FIG. 4B is a side view of the distal segment 214 showingthe alignment assembly 220 of FIG. 4A in a deployed state (e.g., anexpanded configuration). As noted for some of the embodiments of thealignment assemblies 120 discussed above (FIG. 3), the alignmentassembly 220 can be transformed or actuated between the delivery state(FIG. 4A) and the deployed state (e.g., a loop, lasso, coil and/orhelical/spiral configuration, FIG. 4B).

Referring to FIGS. 4A and 4B together, the alignment assembly 220includes an alignment member 224 that has been shape-set to have a loopconfiguration (FIG. 4B), and a side port 222 disposed proximal to adistal end 213 of the alignment assembly 220, or stated another waydisposed distal to a proximal end 219 of the alignment assembly 220.Optionally, the alignment member 224 can be at least partiallysurrounded by a covering 226, such as a sleeve or other coating. Thealignment assembly 220 can define a tubular structure having alow-profile outer dimension D₁ (e.g., circular or non-circulardimension), a longitudinal axis LA₁, and a lumen 228 for slidablyreceiving a guidewire 202 during delivery or removal of the alignmentassembly 220 (FIG. 4A). As described further below, the lumen 228 isdisposed through the alignment member 224 and the side port 222 spansthe covering 226, if present, and the alignment member 224 to provide aguidewire exit path P from the lumen 228 to outside of the alignmentassembly 220 when the alignment member 224 is deployed to the loopconfiguration (FIG. 4B). In the delivery or substantially straightenedstate, the side port 222 is in a closed configuration such that theguidewire 202 is aligned with the longitudinal axis LA₁ of the alignmentassembly 220 (FIG. 4A); however, in the deployed state, for example, theside port 222 is in an open configuration such that the guidewire 202follows the path P, which is aligned with the side port 222, such thatthe guidewire 202 exits the alignment assembly 220 in a non-axial ornon-parallel direction to the longitudinal axis LA₁ at the distalsegment 214 (FIG. 4B).

Referring to FIG. 4A, one embodiment of the alignment assembly 220 maybe restrained in the delivery state (e.g., a generally straight orcollapsed configuration) with the guidewire 202 disposed within thelumen 228 of the alignment assembly 220. The guidewire 202 may besufficiently stiff to keep the alignment member 224 relatively straightand the side port 222 in a closed configuration in the delivery state.In this embodiment, the alignment member 224 conforms to the generalshape of the guidewire 202 during delivery of the catheter 200 throughthe vasculature. It will be understood that, without additional bendingstiffness provided by either the guidewire 202 or another deliveryelement (e.g., straightening sheath, guide catheter, etc.), thealignment assembly 220 will tend to return to the pre-formed shape ofthe alignment member 224 (e.g., loop shape, lasso shape, etc.) as shownin FIG. 4B. When the guidewire 202 is partially retracted or withdrawnfrom at least the distalmost region of the alignment assembly 220 (e.g.,proximal to the side port 222), as illustrated in FIG. 4B, the alignmentmember 224 provides a shape-recovery force sufficient to overcome thestraightening force provided by a distalmost portion 203 of theguidewire 202 such that the alignment assembly 220 can deploy into itsloop-shaped (or, alternatively, lasso-shaped, helical/spiral-shaped)configuration with the side port 222 in the open configuration. Further,because the distalmost portion 203 of the guidewire 202 can remain atleast partially within the alignment assembly 220 while in the deployedstate (by way of example, the deployed state shown in FIG. 4B), theguidewire 202 can impart additional structural integrity to thepositioning of the loop-shaped portion prior to subsequent guidewire 202advancement through the side port 222 and toward the aortic valveleaflets. The columnar strength imparted by the guidewire 202 isexpected to help mitigate or reduce problems associated with keeping thealignment assembly 220 in place through the cardiac cycle (e.g.,systolic blood flow through the aorta).

In an alternate method step, the guidewire 202, including the distalmostportion 203, may be withdrawn completely from the alignment assembly 220while remaining within the tubular component 210 to permit thetransformation of the alignment assembly 220. In yet another methodstep, the guidewire 202 may be withdrawn completely from the shaft 210.In any of the foregoing examples, the clinician can withdraw theguidewire 202 sufficiently to observe transformation of the alignmentassembly 220 to the deployed configuration and/or until an X-ray imageshows that the distalmost portion 203 of the guidewire 202 is at adesired location relative to the alignment assembly 220 (e.g., at leastpartially withdrawn from the alignment assembly 220, or completelywithdrawn from the alignment assembly 220, etc.). In some methods, theextent of withdrawal of the guidewire 202 can be based, at least inpart, on the clinician's judgment with respect to the selected guidewireand the extent of withdrawal necessary to achieve deployment of thealignment assembly 220. In various arrangements, once the alignmentassembly 220 has assumed the deployed state, the guidewire 202 can besubsequently advanced within the alignment assembly 220 to exit the sideport 222 in the non-axial direction and in the direction of the aorticvalve. In some embodiments, the guidewire 202 can be completelywithdrawn from the catheter 200 and a second guidewire (not shown) canbe subsequently advanced through the tubular component 210 and the lumen228 of the alignment assembly 220 to exit the side port 222 when in thedeployed state. For example, in one embodiment, a J-tip guidewire can beused to advance the catheter 200 having the alignment assembly 220through the vasculature, and a straight-tip guidewire can besubsequently advanced following deployment of the alignment assembly 220to cross the aortic valve.

In one embodiment, the side port 222 can be a slit, skive, slice orother hole formed in the components of the alignment assembly 220 on oneside of the tubular component 210 and may form a joint and/or a weakregion (e.g., on an opposite side of the tubular component 210) at whichthe tubular component 210 naturally bends. For example, the side port222 can be formed by removing a slice or skive from the covering 226 andthe alignment member 224 during manufacturing. In other embodiments, theside port 222 can be formed by puncturing a hole or inserting an eyeletor other feature to form an opening through which a guidewire canadvance. In the delivery state, the side port 222 can be in a closed orotherwise inaccessible configuration such that a guidewire 202 advancedthrough the lumen 228 of the tubular component 210 would advance along afirst guidewire path that continues within the lumen 228 to a distalopening 218 at the distal end 213 of the alignment assembly 220 (FIG.4A). When deployed, the side port 222 is positioned along the tubularcomponent 210 in a location proximal of the loop configuration (FIG.4B). In operation, a subsequently advanced guidewire 202 would advancealong a second guidewire path that ends at a bend 240 in the tubularcomponent 210 at or near the side port 222. The portion of the lumen 228proximal to the bend 240 remains uncompromised and a guidewire 202traveling therethrough would exit the side port 222 adjacent the bend240 (FIG. 4B). In other embodiments, the bend 240 can be a feature ofthe alignment member 224 that is set during the manufacturing process.In such embodiments, a punctured hole (not shown) or other added feature(e.g., eyelet) can be positioned in alignment with a portion of thelumen 228 proximal of the side port 222 when the alignment assembly 220is in the deployed state (FIG. 4B).

The pre-formed, loop-shaped configuration of the alignment assembly 220is further illustrated in FIG. 4C, which is a transverse end view of thealignment assembly 220 in the direction of the arrow 4C of FIG. 4B.Referring to FIGS. 4B and 4C together, the distal region of thealignment assembly 220 defines a loop or circular shape in a directionradially outward from a center of curvature C_(C1), and thatself-expands to a deployed geometry within the aorta A (describedfurther below with reference to FIG. 4D). As further illustrated inFIGS. 4B and 4C, transitioning from the bend 240, in the loopconfiguration, the alignment assembly 220 defines or possesses alongitudinal segment 242 followed by circumferential segment 244, whichforms the loop shape about the center of curvature C_(C1). Thelongitudinal segment 242 extends distally and radially, i.e., is angled,from the bend 240 for positioning an origin 246 of the circumferentialsegment 244 in contact with or very close to a wall, annulus or otheranatomy of the region, as described below. In the illustratedembodiment, the distal end 213 of the alignment assembly 220 is also aterminal end 245 of the circumferential segment 244. Referring to FIG.4C, the terminal end 245 of the circumferential segment 244substantially meets and/or is aligned with the origin 246 of thecircumferential segment 244 creating a single loop having a radius R₁.In alternative arrangements, not shown, the terminal end 245 may notmeet the origin 246, such as for example if the loop formed a coil(e.g., wherein the terminal end 245 overlaps with the origin 246). Instill other arrangements, the circumferential segment 244 may notcomplete an entire loop such that there is a gap (wider opening) betweenthe terminal end 245 and the origin 246.

In some embodiments, the radius R₁ of the loop shape formed by thecircumferential segment 244 is sized greater than a radius of an aorticvalve AV such that portions of the circumferential segment 244 can atleast partially rest on an annulus of the aortic valve, and/or engage aninner wall of the aorta. In other embodiments, the radius R₁ is lessthan a radius of an aortic valve such that portions of thecircumferential segment 244 can at least partially rest on cusps of theaortic valve. Additionally, the size of the loop shape (e.g., the radiusR₁) may be selected to engage the aorta, a subannular region of theaortic valve and/or other anatomical features of the patient's anatomywithout blocking or inhibiting a guidewire 202 from crossing the nativevalve, or stated another way to allow the guidewire 202 to pass througha central space 248 that is created or defined by the loop shape (FIG.4C) as the guidewire is maneuvered for crossing the native valve.

As mentioned above, the alignment member 224 may be used to impart aloop shape to the alignment assembly 220. In one embodiment, thealignment member 224 can be a tubular structure comprising a nickeltitanium alloy (e.g., nitinol) multi-filar stranded wire with a lumentherethrough, such as, for example, as sold under the trademark HELICALHOLLOW STRAND (HHS), and commercially available from Fort Wayne Metalsof Fort Wayne, Ind. The alignment member 224 may be formed from avariety of different types of materials, may be arranged in a single ordual-layer configuration, and may be manufactured with a selectedtension, compression, torque, pitch direction, or other characteristics.The HHS material, for example, may be cut using a laser, electricaldischarge machining (EDM), electrochemical grinding (ECG), or othersuitable means to achieve a desired finished component length andgeometry.

Forming the alignment member 224 of nitinol multi-filar stranded wire(s)or other similar materials is expected to provide a desired level ofsupport and rigidity to the alignment assembly 220 without additionalreinforcement wire(s) or other reinforcement features within thealignment assembly 220. In one embodiment, the looped shape structurecan be formed from a shape memory material (e.g., nitinol) wire or tubethat is shaped around a mandrel (not shown) using conventionalshape-setting techniques known in the art. In one specific example,nitinol shape memory wire can typically be heated to approximately 510°C. for approximately 5 minutes followed by a water quench. In anotherembodiment, a flat sheet of nitinol or other shape memory material canbe fabricated and further wrapped about a shape rod or mandrel forpre-forming the loop shape of the alignment member 224. A desiredstiffness of the alignment member 224 and/or alignment assembly 220 canbe provided using variations in a braid or weave pattern, coiledstructures, woven structures and/or wire density as known by one ofordinary skill in the art of fabricating shaped devices. In oneembodiment, the stiffness of the alignment member 224 can vary along alength of the alignment member 224 such as, for example, regions at ornear the side port 222 may have a greater stiffness than regionscomprising the circumferential segment 244. In various embodiments, thestiffness of the guidewire 202 used to deliver the alignment assembly220 to the target region at near the aortic valve AV may be greater thana stiffness of the alignment member 224 such that the alignment assembly220 can be more easily tracked through the vasculature during delivery.

In one embodiment, the covering 226 provides a sleeve or pre-appliedcoating over the alignment member 224 to isolate the material (e.g.,nitinol) of the alignment member 224 (e.g., as shown in FIG. 4A) fromthe vasculature. The covering 226 may be composed of a polymer materialsuch as polyamide, polyimide, polyether block amide copolymer sold underthe trademark PEBAX, polyethylene terephthalate (PET), polypropylene, analiphatic, polycarbonate-based thermoplastic polyurethane sold under thetrademark CARBOTHANE, or a polyether ether ketone (PEEK) polymer orother suitable materials. The material properties and dimensions of thecovering 226 are selected to provide the necessary flexibility for thecovering 226 to readily deform between a relaxed, substantially straightshape and the loop shape configuration of the alignment member 224 inthe deployed state. In other words, the covering 226 is more flexiblethan the alignment member 224 such that the shape of the combinedcomponents is defined in large part by the shape of the alignment member224.

In one embodiment, the alignment member 224 and inner wall of thecovering 226 can be in intimate contact with little or no space betweenthe alignment member 224 and the covering 226 (as best seen in FIG. 4A).In some embodiments, for example, the covering 226 can have a largercross-sectional dimension (e.g., diameter) than the alignment member 224before assembly such that applying hot air to the covering 226 duringthe manufacturing process shrinks the covering onto the alignment member224, as will be understood by those familiar with the ordinary use ofshrink tubing materials. This feature is expected to inhibit oreliminate wrinkles or kinks that might occur in the covering 226 as thealignment assembly 220 transforms from the relatively straight deliverystate (FIG. 4A) to the generally loop-shaped configuration in thedeployed state (e.g., FIG. 4B).

In other embodiments, the alignment member 224 and/or other componentsof the alignment assembly 220 may be composed of different materialsand/or have a different arrangement. For example, the alignment member224 may be formed from other suitable shape memory materials (e.g., wireor tubing besides HHS or nitinol, shape memory polymers, electro-activepolymers) that are pre-formed or pre-shaped into the desired deployedstate. Alternatively, the alignment member 224 may be formed frommultiple materials such as a composite of one or more polymers andmetals.

In some embodiments, the alignment assembly 220 terminates at anatraumatic tip 230 (FIGS. 4A and 4B). The atraumatic tip 230 can be aflexible curved or tapered tip. In one embodiment, the atraumatic tip230 may have a distal opening 232 for accommodating the guidewire 202when the alignment assembly 220 is in the delivery state (FIG. 4A). Thecurvature of the atraumatic tip 230 can be varied depending upon theparticular sizing/configuration of the alignment assembly 220. In someembodiments, the atraumatic tip 230 may also comprise one or moreradiopaque markers 234 (FIG. 4B) and/or one or more sensors (not shown).In one embodiment, the atraumatic tip 230 can be part of the tubularcomponent 210 and/or the alignment assembly 220 (e.g., an extension ofor integral with the alignment assembly 220 and/or alignment member224). In one example, the atraumatic tip 230 can be a more flexibletapered portion (e.g., about 5 to about 7 mm) of the distal end of thealignment member 224. Such an arrangement can be suitable for guidewiredelivery of the alignment assembly 220 to the target location adjacentthe aortic valve. In another embodiment, the atraumatic tip 230 can be aseparate component that may be affixed to the distal end 213 (FIG. 4A)of the tubular component 210 and/or alignment assembly 220 via adhesive,crimping, over-molding, or other suitable techniques. The atraumatic tip230 can be made from a polymer material (e.g., a polyether block amidecopolymer sold under the trademark PEBAX, or a thermoplastic polyetherurethane material sold under the trademarks ELASTHANE or PELLETHANE), orother suitable materials having the desired properties, including aselected durometer. In other embodiments, the atraumatic tip 230 may beformed from different material(s) and/or have a different arrangement.

FIG. 4D illustrates a cut-away view of an aorta A and aortic valve AV ofa patient and showing a partial side view of the intravascular alignmentassembly 220 of FIGS. 4A-4C having a loop-shaped configuration in adeployed state (e.g., expanded configuration) in accordance with afurther embodiment of the present technology. As noted above, thealignment assembly 220 can be transformed or actuated between thedelivery state (FIG. 4A) and the deployed state (e.g., having a radiallyexpanded, loop-shaped configuration, FIGS. 4B-4D), such as followingdelivery of the alignment assembly 220 to the target location downstreamof the aortic valve AV. In one embodiment, the portions of the alignmentmember 224 that are configured to assume the loop configuration can betransformed when the guidewire 202 (FIG. 4A), for example, is pulledproximally while the alignment assembly 220 is held stationary relativeto the target location. Alternatively, the alignment assembly 220 can bepushed distally beyond the distalmost portion 203 of the guidewire 202while the guidewire 202 is held stationary relative to the targetlocation.

The side port 222 as depicted in FIGS. 4B and 4C is also shown in theopen configuration in FIG. 4D. As best seen in FIGS. 4C and 4D, the sideport 222 is oriented toward the central space 248 created by thecircumferential segment 244 of the pre-formed loop configuration. Inoperation, an advancement of the guidewire 202 from the lumen 228 (FIG.4A) through the side port 222 will cross a plane of the pre-formed loopconfiguration through the central space 248 (FIG. 4C) and continuetoward the aortic valve (FIG. 4D).

Referring back to FIG. 4A, in the delivery state the alignment assembly220 has an outer diameter or dimension D₁ that is sized to provide a lowprofile thereto, and an axial length L₁ between the proximal and distalends 219, 213 thereof. As shown in FIG. 4B, in the radially-expandedstate the alignment assembly 220 achieves a loop-shaped configurationthat is characterized, at least in part, by an outer diameter ordimension D₂ and axial length L₂ between the proximal and distal ends219, 213 thereof. In particular, the expanded loop-shaped configurationof the alignment assembly 220 may be characterized by its axial lengthL₂ along the axis of elongation in free space, e.g., not restricted by avessel wall or other structure. As the alignment assembly 220 radiallyexpands from its delivery state, its low-profile outer dimension D₁(FIG. 4A) increases to its radially-expanded outer dimension D₂ (FIGS.4B and 4C) and its axial length decreases. That is, when the alignmentassembly 220 deploys into the loop shape configuration, the distal end213 of the alignment assembly 220 moves axially towards the proximal end219 of the alignment assembly 220 (or vice versa). Accordingly, thedeployed axial length L₂ is less than the unexpanded or delivery axiallength L₁. As such, subsequent to deployment within the aorta A (FIG.4D), the orientation and/or position of the deployed loop-shapedconfiguration within the aorta A may need to be adjusted relative to theaortic valve AV. For example, in one embodiment, the deployed alignmentassembly 220 may need to be moved further downstream toward the aorticvalve AV following deployment (e.g., if the distal end 213 moves axiallytoward the proximal end 219 during deployment). Movement of the deployedalignment assembly 220 within the aorta A can be accomplished, forexample, by pushing the proximal segment (not shown) of the catheter 200from outside of the body in a distal direction (e.g., until the loopconfiguration is in a desired location relative to the aortic valve AV).

As shown in FIG. 4D, the loop-shaped configuration has thecircumferential segment 244 that expands in a direction toward the innerwall of the aorta A such that at least portions of the circumferentialsegment 244 engage the inner wall. Referring back to FIG. 4C, thecircumferential segment 244 can be generally circular when in anunbiased configuration (e.g., when radial expansion of the expandedconfiguration is not limited by an opposing structure); however, inother embodiments, other shapes are possible (e.g., oval, irregularetc.). When deployed within the aorta A or other structure in the body,at least portions of the circumferential segment 244 can be biased, forexample, in a direction radially inward toward the center of curvatureC_(C1) to accommodate the shape of the surrounding anatomical features.With reference to FIGS. 4C and 4D together, and upon deployment withinthe aorta A of the patient, an axis line (not shown) drawn through thecenter of curvature C_(C1) of the circumferential segment 244 issubstantially aligned with (e.g., is substantially coincident with) acentral axis A_(X1) of the ascending aorta A in a manner that positionsthe circumferential segment 244 in contact with the inner wall of theaorta A (or other anatomical structure) while generally positioning theside port 222 in alignment with a center (e.g., leaflet coaptationregion) of the aortic valve AV. In other arrangements, the size, shapeand orientation of the inner wall of the aorta A causes the axis linethrough the center of curvature C_(C1) to be misaligned with a centerand/or leaflet coaptation region of the aortic valve AV. In theseinstances, the clinician can adjust the guidewire path exiting the sideport 222 such that the guidewire path crosses the center and/or leafletcoaptation region of the aortic valve as discussed further herein.

FIGS. 5A-5C are partial side views of the catheter 200 showing thealignment assembly 220 deployed within the aorta A of a patient andillustrating steps in a method for adjusting a guidewire path P (shownas dotted lines P₁, P₂ and P₃, respectively) through the central space248 of the circumferential segment 244 (which substantially forms a loopshape) and across the aortic valve AV. Referring to FIG. 5A, an angleA_(L1) is formed between a portion of the tubular component 210proximally adjacent to the side port 222 and the longitudinal segment242 of the alignment assembly 220, which distally extends from the sideport 222. In an embodiment, the angle A_(L1) may be formed by the bend240, which may be considered to extend between the portion of thetubular component 210 proximally adjacent to the side port 222 and thelongitudinal segment 242 distally adjacent to the side port 222. Whenthe alignment assembly 220 is positioned with respect to the nativeanatomy as shown in FIG. 5A, the bend 240 forms the angle A_(L1) and theguidewire path P₁ is projected to cross the aortic valve AV at pointAV₁. To adjust the alignment assembly 220 to alter the guidewire path P,a clinician can push or pull the proximal segment (not shown) of thecatheter 200 to adjust the angle A_(L) and thereby the guidewire path P.For example, a clinician can push the proximal segment (not shown) ofthe catheter 200 in a distal direction (e.g., along arrow 260) todecrease the angle degree to angle A_(L2) (FIG. 5B). The angle A_(L2)alters the trajectory of the guidewire path P from the side port 222 tothe guidewire path P₂. As illustrated, a guidewire (not shown) followingthe guidewire path P₂ would cross the aortic valve AV at point AV₂.Likewise, a clinician can pull the proximal segment (not shown) of thecatheter 200 in a proximal direction (e.g., in the direction of arrow262) to increase the angle degree to angle A_(L3) (FIG. 5C). The angleA_(L3) alters the trajectory of the guidewire path P along guidewirepath P₃ which crosses the aortic valve AV at point AV₃. With referenceto FIGS. 5A-5C together, a clinician can, in real time, determine adesired target point at which to cross the aortic valve AV (e.g., at acenter of the valve, at a region of leaflet coaptation, etc.) and pushor pull the proximal segment of the catheter 200 to adjust the angleA_(L) and thereby adjust the guidewire path P of a subsequently advancedguidewire exiting the side port 222.

Referring back to FIG. 4D, the alignment assembly 220 is shownpositioned within the aorta A downstream of the aortic valve AV, and thetubular component 210 of the catheter 200 is shown in an intravascularpath extending from the aortic arch AA. Intravascular access to theaortic arch AA and ascending aorta A can be achieved via a percutaneousaccess site in a femoral, brachial, radial, or axillary artery to thetargeted treatment site adjacent the aortic valve AV. Referring to FIGS.3 and 4D together, and as is known in the art, a section of the proximalportion 112 (FIG. 3) of the tubular component 110, 210 is exposedexternally of the patient even as the alignment assembly 120, 220 hasbeen advanced fully to the targeted site in the patient. By manipulatingthe proximal portion 112 (FIG. 3) of the tubular component 110, 210 fromoutside the intravascular path, the clinician may advance the tubularcomponent 110, 210 through the sometimes tortuous intravascular path andremotely manipulate the distal portion 114, 214 of the shaft 110, 210.

With reference to FIGS. 3, 4A and 4D together, the alignment assembly120, 220 can extend intravascularly to the target site over theguidewire 102, 202 using an OTW technique (FIG. 3). As noted previously,the distal end 113, 213 of the tubular component 110, 210 and/oralignment assembly 120, 220 may define a lumen 128, 228 or passagewayfor receiving the guidewire 102, 202 (e.g., via the distal opening 118,218) for delivery of the catheter 100, 200 using either OTW or RXtechniques. At the treatment site, the guidewire 102, 202 can be atleast partially axially withdrawn or removed, and the alignment assembly120, 220 can transform or otherwise be moved to a deployed arrangementhaving the loop configuration as described above with respect to FIGS.3-4D. The guidewire 102, 202 may comprise any suitable medical guidewiresized to slidably fit within the lumen 128, 228 of tubular component110, 210 and/or other features of the catheter 100, 200, such as thehandle 104 (FIG. 3). In one particular embodiment, for example, theguidewire 102, 202 may have a diameter of 0.356 mm (0.014 inch). Inother embodiments, the alignment assembly 120, 220 may be delivered tothe target site within a guide or straightening sheath (not shown) withor without using the guidewire 102, 202. When the alignment assembly120, 220 is at the target site, the straightening sheath may be at leastpartially withdrawn or retracted and the alignment assembly 120, 220 canbe transformed into the deployed arrangement. In still otherembodiments, the tubular component 110, 210 may be steerable itself suchthat the alignment assembly 120, 220 may be delivered to the target sitewithout the aid of the guidewire 102, 202 and/or straightening sheath.

With continued reference to FIGS. 3 and 4D together, image guidance,e.g., computed tomography (CT), fluoroscopy, intravascular ultrasound(IVUS), optical coherence tomography (OCT), intracardiacechocardiography (ICE), or another suitable guidance modality, orcombinations thereof, may be used to aid the clinician's positioning andmanipulation of the alignment assembly 120, 220 at the target site. Insome embodiments, image guidance components (e.g., IVUS, OCT) can beintegrated with the catheter 100, 200, the tubular component 110, 210and/or run in parallel with the catheter 100, 200 to provide imageguidance during positioning and deployment of the alignment assembly120, 220, crossing of the heart valve with the guidewire 102, 202 and/orremoval of the alignment assembly 120, 220. In a particular example,image guidance components (e.g., IVUS or OCT) can be coupled to at leastthe alignment assembly 120, 220 to provide three-dimensional images ofthe vasculature proximate the target site to facilitate positioning ordeploying the alignment assembly 120, 220 within the target site (e.g.,with the aorta proximate to the aortic valve).

FIG. 6A is block diagram illustrating a method 600 of crossing an aorticvalve with a guidewire in a patient with the catheter 200 describedabove with reference to FIGS. 4A-5C and in accordance with an embodimentof the present technology. Referring to FIG. 6A (and with additionalreference to FIGS. 4A-5C), the method 600 can include advancing acatheter 200 and a first guidewire 202 a (illustrated 202 in FIG. 4A)through the vasculature of a patient to a location downstream of theaortic valve (block 602). In one embodiment, the first guidewire 202 ais disposed in a proximal segment (not shown) and a distal segment 214of the catheter 200 such that the catheter 200 conforms to the shape ofthe first guidewire 202 a. In a particular example, the first guidewire202 a conforms or holds the proximal and distal segments 214 in a lowprofile delivery configuration.

The method 600 can also include retracting the first guidewire 202 aproximal of the distal segment (e.g., proximal of the side port 222) ofthe catheter 200 (block 604). Retraction of the first guidewire 202 a inthe proximal direction causes at least a portion of the distal segmentof the catheter 200 (e.g., the alignment assembly 220) to deploy ortransform to a loop configuration, such as to bring the distal segment214 of the tubular component 210 in apposition with a wall or walls of avessel (e.g., aorta) adjacent to the aortic valve. The method 600 canfurther include distally advancing a second guidewire 202 b such thatthe second guidewire 202 b exits the side port 222 proximal of a distalend 213 of the alignment assembly 220 towards the leaflets of the aorticvalve (block 606). In one embodiment, the advancing step is performedduring systole of the cardiac cycle (e.g., when the leaflets of theaortic valve are substantially open). In some embodiments, the secondguidewire 202 b can be the same as the first guidewire 202 a. Forexample, the first guidewire 202 a can be retracted in a proximaldirection (e.g., proximal of the distal segment 214) but not removedfrom the tubular component 210. Following deployment of the alignmentassembly 220, the first guidewire 202 a can be advanced distally to exitthe port 222. In other embodiments, the first guidewire 202 a can be aJ-tip guidewire for positioning the catheter 200 at the target locationproximal to the aortic valve and the second guidewire 202 b is astraight-tip guidewire for crossing the aortic valve.

Following the step of advancing the second guidewire 202 b (block 606),a clinician can assess if the second guidewire successfully crosses theaortic valve (decision block 608). If the clinician determines that thesecond guidewire 202 b crosses the aortic valve, the method 600 can end(block 610). In some embodiments, the catheter 200 can be removed fromthe patient after crossing the aortic valve with the second guidewire202 b. If the second guidewire 202 b did not advance between theleaflets of the aortic valve, the process can continue with a method 650as illustrated in FIG. 6B (with additional reference to FIGS. 4A-5C).

Referring to FIG. 6B, the method 650 can include adjusting the locationof the side port 222 relative to a center of the aortic valve (block652). In one embodiment, a clinician can cause the side port 222 to beadjusted relative to the center (or to a region of leaflet coaptation)of the aortic valve by pulling or pushing on a proximal segment (notshown) of the catheter 200 in a proximal or distal direction,respectively (see FIGS. 5A-5C). By pulling or pushing on the proximalsegment, the guidewire path from the side port 222 (and through the loopshape created by the alignment assembly 220) can be altered at leastalong a single axis across the aortic valve. After adjusting thelocation of the side port 222, the method 650 can include advancing thesecond guidewire 202 b again (block 254). Following the step ofadvancing the second guidewire 202 b (block 654), the clinician canagain assess if the second guidewire 202 b successfully crosses theaortic valve (decision block 656). If the clinician determines that thesecond guidewire 202 b has crossed the aortic valve, the method 650 canend (block 658). If the second guidewire 202 b did not advance betweenthe leaflets of the aortic valve, the process can continue back to block652 with adjusting the location of the side port 222 (as illustrated inFIG. 6B), and the method 650 concludes (block 658) when the secondguidewire crosses the aortic valve. Following advancement of the secondguidewire 202 b between the leaflets of the aortic valve, the catheter200 can be retracted through the vasculature and removed from thepatient.

Additional Embodiments of Catheters Having Shape Set Loop Configurations

FIG. 7A is an enlarged, longitudinal cross-sectional view of a distalsegment 314 of an elongated hollow shaft or tubular component 310 of acatheter 300 having an alignment assembly 320 in a delivery state (e.g.,a low-profile or collapsed configuration) and in accordance with anotherembodiment hereof. FIG. 7B illustrates a cut-away view of an aorta A andan aortic valve AV of a patient and a partial side view of the distalsegment 314 of the catheter 300 of FIG. 7A with the alignment assembly320 in a deployed state (e.g., an expanded configuration). The catheter300 includes features generally similar to the features of the catheter200 described above with reference to FIGS. 4A-5C. For example, thecatheter 300 includes the tubular component 310 and the alignmentassembly 320 at the distal segment 314 of the tubular component 310.Additionally, the alignment assembly 320, as discussed above withrespect to the alignment assembly 220, can be transformed or actuatedbetween the delivery state (FIG. 7A) and the deployed state having ashape set or pre-formed loop (or other coiled, helical/spiral)configuration (FIG. 7B). However, the alignment assembly 320 differsfrom the alignment assembly 220 in that a shape set loop configurationachieved by the alignment assembly 320 directs the distal segment 314 ofthe tubular component 310 to loop or coil in a proximal direction, orstated another way, loop back towards the proximal segment (not shown)of the tubular component 310. Accordingly, the loop feature of thealignment assembly 320 is configured to be deployed in a verticalorientation along the ascending aorta (e.g., parallel to a longitudinalaxis LA₂ of the catheter 300; FIG. 7A).

Referring to FIG. 7A, the alignment assembly 320 includes an alignmentmember 324 disposed within a covering 326. In another arrangement, thealignment member 324 can have a coating over a surface of the alignmentmember 324. In other arrangements, the catheter 300 and/or the alignmentassembly 320 may not include the covering 326. The tubular component 310can include a first lumen 328 a for accommodating a first guidewire 302a and a second lumen 328 b for accommodating a second guidewire 302 b.In one embodiment, the first guidewire 302 a can be a positioningguidewire (e.g., a J-tip guidewire or other medical guidewire) used todirect the catheter 300 through the vascular and to the target locationwithin the aorta and adjacent to (e.g., downstream of) the aortic valve.The first lumen 328 a, provided for slidably receiving the firstguidewire 302 a during delivery or removal of the alignment assembly 320(FIG. 7A), can span between a first opening (not shown) at a proximalend of the catheter 300 and a second opening 318 at the distal end 313of the tubular component 310. As such, the alignment assembly 320 may berestrained in the delivery state (FIG. 7A) with the first guidewire 302a disposed within the lumen 328 a. In other embodiments, a straighteningsheath, guide catheter, or other straightening device may be used inlieu of the first guidewire 302 a to retain the alignment assembly 320in the delivery state.

Referring to FIGS. 7A and 7B together, when the first guidewire 302 a isretracted proximal of the alignment assembly 320, the alignment member324 provides a shape-recovery force sufficient to overcome thestraightening force provided by a distalmost portion 303 a of the firstguidewire 302 a such that the alignment assembly 320 can deploy into itsshape set curved or looped (or, alternatively, coil,helical/spiral-shaped) configuration. As illustrated in FIG. 7B, theloop configuration of the alignment member 324 is defined by acircumferential segment 344 initiating at an origin or proximal end 346and extending through a terminal end 345, which is also the distal end313 of the tubular component 310, and which curves about a center ofcurvature C_(C2). In the embodiment illustrated in FIG. 7B, an axis line(not shown) drawn through the center of curvature C_(C2) issubstantially perpendicular to the longitudinal axis LA₂ (FIG. 7A) andto a central axis A_(X1) of the ascending aorta A. Also in thisembodiment, by way of example and not limitation, the terminal end 345of the circumferential segment 344 does not align with the origin 346and is disposed relative thereto in a direction radially inward towardthe center of curvature C_(C2). Further winding of the circumferentialsegment 344 (e.g., by pushing the proximal segment (not shown) of thecatheter 300 in the distal direction) would result in additional coilsor loops having increasingly smaller pitch being formed. In someembodiments, the loop configuration can have concentric winding whereinadditional numbers of loops or coils having the progressively smallerpitch can be formed. At least a portion of the circumferential segment344 defining the outside loop of the coil (if additional coils arepresent) can engage an inner wall of the aorta A for stabilizing and/ororienting the alignment assembly within the aorta.

In some embodiments, the distalmost portion 303 a of the first guidewire302 a can remain at least partially within the alignment assembly 320(e.g., proximal to the origin 346 of the circumferential segment 344)while in the deployed state (e.g., FIG. 7B), such that the firstguidewire 302 a can impart additional structural integrity to thepositioning of the alignment assembly 320 when it is in a loopconfiguration prior to a subsequent advancement of the second guidewire302 b within the second lumen 328 b and through a side port 322 in adirection generally toward the aortic valve leaflets. As discussed withrespect to the catheter 200, this feature may provide additionalstability and proper alignment to the alignment assembly 320 during thecardiac cycle and/or during placement of the second guidewire 302 bacross the aortic valve. After successfully crossing the aortic valve AVwith the second guidewire 302 b, the first guidewire 302 a may bere-advanced through the first lumen 328 a to at least partiallystraighten the alignment assembly 320 (e.g., transition the alignmentassembly 320 from the deployed state to the delivery state) prior toremoval of the catheter 300 from the vasculature. In other embodiments,at least partial advancement of the first guidewire 302 a through thefirst lumen 328 a can be used to reposition or reorient the alignmentassembly 320 during attempts to cross the aortic valve with the secondguidewire 302 b. In still other embodiments, the first guidewire 302 acan be removed from the alignment assembly 320 and/or the tubularcomponent 310 entirely.

The alignment assembly 320 also includes the side port 322 being formedthrough each of the coating 326 and the alignment member 324 to providea guidewire exit path from the second lumen 328 b to an exterior of thealignment assembly 320 when the alignment member 324 is deployed (FIG.7B). In operation, and when in the delivery state, the second guidewire302 b is not advanced beyond the side port 322 (FIG. 7A). Once thealignment assembly 320 is deployed, the side port 322 is positionedalong an outside curve of the circumferential segment 344 and generallyoriented toward the aortic valve (FIG. 7B). Advancement of the secondguidewire 302 b in the distal direction causes the second guidewire 302b to exit the side port 322 and continue in the direction of the aorticvalve AV. In the arrangement shown in FIGS. 7A and 7B, the second lumen328 b terminates at the side port 322 and the alignment assembly 320further includes a deflector 370 at the termination of the second lumen328 b to deflect the second guidewire 302 b towards the side port 322.In one embodiment, the deflector 370 can be a slanted surface (e.g., a45° slant or other slant) facing at least partially toward the side port322 and which causes the second guidewire 302 b to deflect (e.g., changecourse) from its travel along the guidewire path provided by the secondlumen 328 b and to thereby exit from the side port 322 in a non-axialdirection. The deflector 370 may change the course of the direction ofthe second guidewire 302 b by a defined deflection angle A_(D1). In aparticular example, the deflection angle A_(m) can be about 45°. Inother embodiments, the deflection angle A_(D1) can be between about 15°and about 90°. In some arrangements, the deflector 370 can be a separatecomponent of the alignment assembly 320 that is coupled to and/orretained within a terminal portion of the second lumen 328 b. Forexample, the deflector can be a metal, plastic, rubber, or other moldedmaterial for providing the slanted deflective surface at the side port322. In other embodiments, the deflector 370 may be integral with thealignment member 324.

In other embodiments, the second lumen 328 b may not include a deflector370. In these embodiments, the curve of the circumferential segment 344,at least at the location of the side port 322, may be sufficient toallow the second guidewire 302 b to advance through a portion of thesecond lumen 328 b proximal to the side port 322 and to then exit viathe side port 322. In an embodiment, a curved portion of the lumen 328 bmay be continuous with the side port 322 such that distal advancement ofthe second guidewire 302 b through the second lumen 328 b wouldeventually cause the tip of the second guidewire 328 b to exit throughthe side port 322 and continue toward the central region of the aorticvalve, when the alignment assembly 320 is in the deployed state. Forexample, the side port 322 is in an open configuration when thealignment assembly 320 is in the deployed state such that the guidewirepath is aligned with the side port 322 and exits the alignment assembly320 in a non-axial or non-collinear direction to a curvilinear axis CA₁defined by the circumferential segment 344 when the alignment member 324is in a loop configuration (FIG. 7B).

In some embodiments, the tubular component 310 and alignment assembly320 may only include a single lumen 328 and the first guidewire 302 amay or may not be the same as the second guidewire 302 b. For example,the same guidewire 302 a that is used to deliver the alignment assembly320 to the target location may also be able to exit the side port 322(e.g., the guidewire 302 a can be subsequently advanced followingdeployment of the alignment assembly 320). In other embodiments, thetubular component 310 and the alignment assembly 320 may only include asingle lumen 328 but the features of the first and second guidewires 302a, 302 b may be different. For example, a first guidewire 302 a used fordelivery may be a J-tip guidewire and the second guidewire 302 b used tocross the aortic valve may be a straight-tip guidewire. In furtherexamples, the second guidewire 302 b may be more flexible than the firstguidewire 302 a.

Once the alignment assembly 320 is deployed, a clinician may be able tovisually detect (e.g., using image guidance as discussed above) if theorientation of the guidewire path from the side port 322 is aligned withthe center region (e.g., a leaflet coaptation region) of the aorticvalve. If during advancement of the second guidewire 302 b or before, itis determined that the guidewire path needs adjustment, the cliniciancan adjust the location of the side port 322 relative to the aorticvalve by pushing or pulling on the proximal segment (not shown) of thetubular component 310.

FIG. 8 is a perspective view of a distal segment 414 of an elongateshaft 410 of a catheter 400 with an intravascular alignment assembly 420in a deployed state (e.g., an expanded configuration) adjacent an aorticvalve AV in a patient in accordance with a further embodiment hereof.The catheter 400 includes features generally similar to the features ofthe catheters 200, 300 described above with reference to FIGS. 4A-7B.For example, the catheter 400 includes the tubular component 410 and thealignment assembly 420 at the distal segment 414 of the tubularcomponent 410. Additionally, the alignment assembly 420, as discussedabove with respect to the alignment assembly 220, can be transformed oractuated between the delivery state (not shown) and the deployed statehaving a shape set loop (or other coiled, helical/spiral) configuration(FIG. 8). For example, the catheter 400 can be delivered to the targetregion within the aorta A and downstream of the aortic valve AV whilemaintained in the delivery state using OTW approach as described. Inanother embodiment, a straightening sheath can be used to maintain thelow-profile configuration during delivery.

As illustrated, the loop configuration of the alignment assembly 420 hassimilarities to the loop configuration of the alignment assembly 220shown in FIGS. 4B-4D. For example, an axis line (not shown) drawnthrough a center of curvature C_(C3) about which a circumferentialsegment 444 curves is substantially coincident with a central axisA_(X1) of the ascending aorta A. However, the alignment assembly 420differs from the alignment assembly 220 in that the loop configurationcontrolled by the shape set form of an alignment member (not shown)includes a distal tip segment 447 extending from a terminal end 445 ofthe circumferential segment 444 and which extends across a central space448 created by the circumferential segment 444.

As shown in FIG. 8, the alignment assembly 420 also includes a side port422 disposed within the distal tip segment 447 that is oriented to guidea guidewire 402 towards the leaflet coaptation region of the aorticvalve AV. The guidewire 402 is sufficiently flexible such that it willtend to conform to the loop configuration of the alignment member (notshown). The guidewire 402 is slidably received within a guidewire lumen(not shown) defined by the tubular component 410 and the alignmentmember 420 and which terminates at the side port 422. The side port 422can include a deflector 470, which can be similar to the deflector 370of the catheter 300. The deflector 470 can control the exit trajectoryof the guidewire 402 from the lumen and through the aortic valve AV asshown in the FIG. 8. The tubular component 410 and the alignmentassembly 420 may have more than one lumen (e.g., as illustrated in theembodiment of the catheter 300 shown in FIG. 7A), such as, for example,for slidably receiving a delivery guidewire (not shown) in an OTWapproach, and for accommodating the guidewire 402 across the aorticvalve.

Selected Embodiments of Catheter Assemblies Having a Plurality of SidePorts

FIG. 9A is an exploded view of a catheter assembly 500 (“catheter 500”)having an elongated hollow shaft or tubular component 510 and analignment assembly 520 for delivering a guidewire 504 across a heartvalve in accordance with another embodiment hereof, and FIG. 9B is anenlarged sectional view of the alignment assembly 520 of the catheter500 shown in FIG. 9A. As noted for some of the embodiments of thealignment assemblies 120 discussed above with reference to FIG. 3, thealignment assembly 520 can include a tubular outer support structure 524having a plurality of side ports 522 a-522 d spaced-apart along a distalsegment 514 of the tubular component 510.

Referring to FIGS. 9A and 9B together, the catheter 500 has the tubular,tubular component 510 having a proximal end 511 at an origin of aproximal segment 512 and a distal end 513 at a terminus of the distalsegment 514. The alignment assembly 520 is located along the distalsegment 514 and is configured to be located at the target locationwithin the aorta downstream of the aortic valve. The tubular component510 can be a generally hollow body having a lumen 528 for accommodatinga delivery or first guidewire 502 (e.g., shown as a J-tip guidewire inFIG. 9B) through a distal opening 518 and a proximal opening (not shown)using an OTW arrangement. In another embodiment, the tubular component510 of the catheter 500 may be configured to be steerable such that thealignment assembly 520 may be delivered to the target site without theaid of the first guidewire 502.

The alignment assembly 520 includes an outer body, such as the supportstructure 524 that can be integral with tubular component 510, as shownin FIG. 9B, or in another arrangement, can be a component coupled to thetubular component 510 in a manner that permits the lumen 528 to becontinuous between the tubular component 510 and the support structure524. The support structure 524 can define a tubular structure having alow-profile outer dimension D₃ (e.g., circular or non-circulardimension), a longitudinal axis LA₃, and the lumen 528 for slidablyreceiving a guidewire, such as the first guidewire 502 (FIG. 9B), duringdelivery or removal of the alignment assembly 520. As described furtherbelow, the lumen 528 is disposed through the support structure 524 andthe plurality of spaced apart side ports 522 a-522 d span the wall ofthe support structure 524 to provide various guidewire exit paths fromthe lumen 528 to an exterior of the alignment assembly 520 when thealignment assembly is located adjacent the aortic valve (discussedfurther below with respect to FIG. 10).

Referring back to FIGS. 9A and 9B, the alignment assembly 520 alsoincludes a wire guide 530 that is slidably disposed within the supportstructure 524. The wire guide 530 can have a lumen 532 that isconfigured to slidably receive the second guidewire 504 (e.g., aguidewire for delivering across the aortic valve) through a proximalguidewire port 533 (shown as dotted line in FIG. 9A) disposed within afirst portion 534 of the wire guide 530 and to direct the secondguidewire 504 through a distal guidewire port 535 disposed at a terminalend of a second portion 536 of the wire guide 530. As shown best in FIG.9B, the wire guide 530 is an elongate tubular structure configured ordimensioned to slide within the lumen 528 of the support structure 524,and to be slidable relative to the side ports 522 a-522 d. Axialmovement of the wire guide 530 relative to the support structure 524aligns the distal guidewire port 535 with one of the plurality ofspaced-apart side ports 522 a-522 d. As shown in FIG. 9B, the distalguidewire port 535 is aligned with the side port 522 b. Rotationalmovement of the wire guide 530 relative to the support structure 524radially positions the distal guidewire port 535 allowing for alterationof a radial trajectory of a guidewire exiting from an axially alignedside port 522 a-522 d. In operation, a clinician can push or pull on thefirst portion 534 of the wire guide 530, or rotate from the firstportion 534 of the wire guide 530, while holding the support structure524 steady within the aorta. In alternative arrangements, the supportstructure 524 can be manipulated relative to the wire guide 530 bypushing or pulling on the proximal segment 512 of the tubular component510 until the distal guidewire port 535 is aligned with the desired sideport 522 b. Once the distal guidewire port 535 is aligned with thedesired side port 522 (e.g., side port 522 b), the second guidewire 504can be advanced through the lumen 532 to exit the aligned side port 522b.

As shown in FIGS. 9A and 9B, the plurality of spaced-apart side ports522 a-522 d may be distributed on the support structure 524 in a desiredarrangement. For example, the axial distances between the side ports 522a-522 d may be provided to allow for selectivity in a preferredguidewire path when advancing a guidewire across the aortic valve in avariety of a patients having variable sized and shaped anatomy.Referring to FIG. 9B, the axial distance 523 may be in a range ofbetween approximately 2 mm to approximately 1 cm. In a particularembodiment, the axial distance 523 may be in the range of approximately2 mm to approximately 10 mm. In another embodiment, the side ports 522a-522 d may be spaced apart approximately 30 mm from each other.

In the illustrated embodiment, the side ports 522 a-522 d are alignedcircumferentially with each other along a length L₃ of the alignmentassembly 520; however, in other arrangements, the side ports can be bothlongitudinally and circumferentially off-set from one another. FIG. 9Aillustrates four side ports 522 a-522 d longitudinally spaced-apart fromone another in a distal region of the alignment assembly 520; however,one of ordinary skill in the art will recognized that there can be moreor less than four side ports 522 provided on support structure 524. Insome embodiments, and as illustrated in FIG. 9A, the individual sideports 522 a-522 d can have the shape of a partial circumferential slotformed in the support structure 524, thereby allowing for alteration ofa radial trajectory of a guidewire exiting from an aligned slot byrotation of the wire guide 530, and particularly the distal guidewireport 535, relative thereto. In other embodiments, not shown, the sideports 522 a-522 d can be circular, oblong, or other shaped holesdisposed or formed in the support structure 524.

In one embodiment, the support structure 524 can include a solidstructural element, e.g., a wire, tube, coiled or braided cable. Thesupport structure 524 may be formed from biocompatible metals and/orpolymers, including polyethylene terephthalate (PET), polyamide,polyimide, polyethylene block amide copolymer, polypropylene, orpolyether ether ketone (PEEK) polymers. In some embodiments, componentsof the support structure 524 may be formed from stainless steel,nitinol, silver, platinum, nickel-cobalt-chromium-molybdenum alloy, or acombination of such materials. In one particular embodiment, forexample, the support structure 524 can include a shape memory material,such as spring temper stainless steel or nitinol. Furthermore, inparticular embodiments, the support structure 524 may be formed, atleast in part, from radiopaque materials that are capable of beingfluoroscopically imaged to allow a clinician to determine if thealignment assembly 520 is appropriately placed and/or deployed in theaorta and/or adjacent the aortic valve. Radiopaque materials mayinclude, for example, barium sulfate, bismuth trioxide, bismuthsubcarbonate, powdered tungsten, powdered tantalum, or variousformulations of certain metals, including gold and platinum, and thesematerials may be directly incorporated into structural elements (e.g.,at or aligned with side ports 522, the distal end 513 of the tubularcomponent 510, etc.) or may form a partial or complete coating on thesupport structure 524.

FIG. 10 is a perspective view of the distal segment 514 of the tubularcomponent 510 of the catheter assembly 500 of FIG. 9A within an aorta Aand adjacent to the aortic valve AV of a patient in accordance with afurther embodiment hereof. As illustrated in FIG. 10, the alignmentassembly 520 can be transluminally delivered using various arterialroutes to the target location as described previously and as known inthe art. The distal end 513 of the distal segment 514 can be placedagainst the native aortic valve annulus (e.g., along one edge of theannulus). Imaging guidance (e.g., fluoroscopy) can be used by theclinician to determine which side port 522 a-522 d is most likely toprovide the desired guidewire path through the leaflet coaptation regionof the aortic valve AV. In one embodiment, the side ports 522 a-522 dcan have respective radiopaque markers 525 or sensors (not shown) forvisualizing the location of and/or differentiating the side ports 522a-522 d in situ. Once a side port 522 a-522 d is determined, the distalguidewire port 535 is axially aligned with the selected side port (e.g.,side port 522 a in FIG. 10), and the guidewire 504 can be advancedthrough the side port 522 a and toward the aortic valve AV.

Referring back to FIGS. 9A and 9B, the wire guide 530 can be providedwith a pre-formed or shape set at the second portion to provide thedistal guidewire port 535. For example, the wire guide 530 can have abend or turn that orients the guidewire 504 to exit the lumen 532 andexit through the aligned side port 522. In other arrangements, however,the wire guide 530 is not pre-shaped or shape set to accommodate thedesired redirection of the second guidewire 504 out of the lumen 532.FIG. 11 is an enlarged sectional view of the second portion 536 of awire guide 530 with a deflector 570 for directing a guidewire 504through the distal guidewire port 535 at a deflection angle A_(D2) inaccordance with an embodiment of the present technology. In thealternative embodiment illustrated in FIG. 11, the distal guidewire port535 is disposed within the wire guide 530 in a location proximal of adistal end 537 of the second portion 536. The deflector 570 can besimilar to the deflector 370 (FIG. 7A) discussed above with respect tothe catheter 300. In one embodiment, the deflector 570 can reorient aguidewire 504 as it is distally advanced from the lumen 532 to exit arespective side port 522. In some instances, the deflector 570 can havea deflector surface angled at about 45° with respect to a longitudinalaxis of the wire guide 530. In other embodiments, the deflector surfaceof the deflector 570 can have a different slant or angle that decreasesor increases the deflection angle A_(D).

FIGS. 12A and 12B are enlarged planar side views of the catheter 500 ofFIGS. 9A and 9B showing a guidewire 504 exiting a selected side port 522at various rotation angles RA₁ in accordance with an embodiment of thepresent technology. Referring to FIGS. 12A and 12B together, the supportstructure 524 includes the side port 522, which is shaped or formed as acircumferential slot, disposed therein. The rotation of the wire guide530 about the longitudinal axis LA₃ of the alignment assembly 520 causesthe distal guidewire port 535 to be selectively oriented along thecircumferential slot of the side port 522. For example, acounterclockwise rotation of the wire guide 530 about the longitudinalaxis LA₃ positions the distal guidewire port 535 towards a first end 527of the circumferential slot of the side port 522 (FIG. 12A), while aclockwise rotation of the wire guide 530 about the longitudinal axis LA₃positions the distal guidewire port 535 towards a second end 529 of thecircumferential slot of the side port 522 (FIG. 12B). In a particularexample, the circumferential slot may encompass up to 90° of the outercircumference of the support structure 524 and the rotational angle RA₁at which the guidewire 504 exits the selected side port 522 can bebetween 0° and 90° with reference to the slot opening. Accordingly, thealignment assembly 520 can provide a clinician control over the angle ofrotation RA₁ as well as selection of which side port 522 from aplurality of spaced apart side ports best aligns a guidewire path acrossthe aortic valve AV.

FIG. 13 is a perspective view of the catheter 500 shown in FIG. 9Aillustrating an alignment guide 580 disposed on an outer surface thefirst portion 534 of the wire guide 530 in accordance with anotherembodiment hereof. As illustrated in FIG. 13, the alignment guide 580provides a visual representation of the position of the distal guidewireport 535 (shown in FIGS. 9B and 10) relative to the plurality ofspaced-apart side ports 522 a-d on the support structure 524. In theexample illustrated in FIG. 13, the alignment guide 580 can communicateto the clinician which of the plurality of side ports 522 that the wireguide 530 (and thereby the guidewire 504) is currently aligned withusing the circumferential indicator lines 582 b-d (and line 582 a, notshown). Alignment of the circumferential indicator lines 582 with theproximal end 511 of the support structure 524, or proximal face, surfaceor edge thereof, can communicate to the clinician which of the sideports 522 a-522 d is currently aligned with the distal guidewire port535. In the illustrated example, the distal guidewire port 535 (notvisible in FIG. 13) is aligned with side port 522 b as indicated by theline 582 b at the proximal end 511 of the support structure 524.

The alignment guide 580 may also provide rotation indicator lines 584for selecting a rotation angle RA₁ (FIGS. 12A and 12B) for aligning thedistal guidewire port 535 within a circumferential slot of the selectedside port (e.g., side port 522 b). In the illustrated example, thealignment guide 580 can have a longitudinal rotation indicator line 584that is substantially aligned with the distal guidewire port 535 (FIGS.9B and 10) at the second portion (not shown). Likewise the proximal end511 of the tubular component 510 can include a first rotation indicatormarker 586 generally aligned with the first end 527 of thecircumferential slots of the side ports 522 a-522 d, and a secondrotation indicator marker 588 generally aligned with the second end 529of the circumferential slots of the side ports 522 a-522 d. Byrotationally adjusting the wire guide 530 such that the longitudinalrotation indicator line 584 is between the first rotation indicatormarker 586 and second rotation indicator marker 588, the guidewire 504(not shown) can exit the aligned side port 522 b at one of variousselected rotation angles RA₁ (by example, rotation angles RA₁ as shownin FIGS. 12A and 12B). In operation, a guidewire (not shown) can bereceived at the proximal guidewire port 533 and be advanced through thewire guide 530 to exit the distal guidewire port 535 and through a sideport (e.g., side port 522 a-522 d) as selected using the alignment guide580. A clinician can use image guidance to determine where the aorticvalve AV is in relationship to one or more side ports 522 (FIG. 10), andthen further use the alignment guide 580 to facilitate delivery ofguidewire 504 in the pre-selected manner.

FIG. 14A is block diagram illustrating a method 1400 for crossing anaortic valve with a guidewire in a patient using the catheter 500 ofFIG. 9A and in accordance with an embodiment hereof. Referring to FIG.14A (and with additional reference to FIGS. 9A-13), the method 1400 caninclude advancing a support structure 524 and a first guidewire 502through the vasculature of a patient to a location downstream of theaortic valve (block 1402). In one embodiment, the first guidewire 502 isdisposed in a proximal segment 512 and a distal segment 514 of thetubular component 510 and/or support structure 524.

The method 1400 can also include axially sliding a wire guide 530 withinthe support structure 524 such that a distal guidewire port 535 of thewire guide 530 is axially aligned with one of a plurality of side ports522 disposed in the distal segment 514 of the support structure 524(block 1404). The method 1400 can further include advancing a secondguidewire 504 distally through the wire guide 530 such that the secondguidewire 504 exits the aligned side port 522 of the support structure524 towards the leaflets of the aortic valve (block 1406). In oneembodiment, the advancing step is performed during systole of thecardiac cycle (e.g., when the leaflets of the aortic valve aresubstantially open). In certain embodiments, the first guidewire 502 canbe a J-tip guidewire for positioning the catheter 500 at the targetlocation proximal to the aortic valve and the second guidewire 504 is astraight-tip guidewire for crossing the aortic valve.

Following the step of advancing the second guidewire 504 (block 1406), aclinician can assess if the second guidewire successfully crosses theaortic valve (decision block 1408). If the clinician determines that thesecond guidewire 504 crosses the aortic valve, the method 1400 can end(block 1410). In some embodiments, the catheter 500 can be removed fromthe patient after crossing the aortic valve with the second guidewire504. If the second guidewire 504 did not advance between the leaflets ofthe aortic valve, the process can continue with method 1450 asillustrated in FIG. 14B (with additional reference to FIGS. 9A-11).

Referring to FIG. 14B, the method 1450 can include at least partiallyretracting the second guidewire 504 (block 1452) and adjusting thelocation of the distal opening of the wire guide 530 relative to thesupport structure 524 to change at least one of the aligned side port522 and a rotational angle along circumference of the support structure524 (block 1454). In one embodiment, a clinician can realign the distalguidewire port 535 with another side port 522, or in another embodiment,change a rotational angle RA₁ by pushing or pulling and/or rotating thewire guide 530 within the support structure 524. By adjusting thealigned side port 522 and/or the angle of rotation, the guidewire pathfrom the side port 522 can be substantially aligned with the aorticvalve (e.g., a leaflet coaptation region). After the adjusting step, themethod 1450 can include advancing the second guidewire 504 again (block1456). Following the step of advancing the second guidewire 504 (block1456), the clinician can again assess if the second guidewire 504successfully crosses the aortic valve (decision block 1458). If theclinician determines that the second guidewire 504 crosses the aorticvalve, the method 1450 can end (block 1460). If the second guidewire 504did not advance between the leaflets of the aortic valve, the processcan continue back to block 1452 with at least partially retracting thesecond guidewire and block 1454 with adjusting the location of thedistal opening of the wire guide 530 relative to the support structure524 (as illustrated in FIG. 14B), and the method 1450 concludes (block1458) when the second guidewire crosses the aortic valve. Followingadvancement of the second guidewire 504 between the leaflets of theaortic valve, the catheter 500 can be retracted through the vasculatureand removed from the patient.

Additional Embodiments

Features of the catheters, catheter assemblies and guidewire deliverysystem components described above and illustrated in FIGS. 3-14B can bemodified to form additional embodiments configured in accordanceherewith. For example, the catheters 200, 300 and 400 can include aplurality of side ports and side port selection means such as thosedescribed with reference to the catheter apparatus 500 illustrated inFIGS. 9A-11. Similarly, the support structure of the catheter 500illustrated in FIGS. 9A-11 can have pre-formed or shape set features,such as bends, loops, coils or spirals for orienting the plurality ofside ports towards the targeted heart valve. Additionally, cathetershaving only one guidewire lumen can be provided with more than one lumenand catheters shown having more than one lumen for slidably receiving aguidewire can be provided with a single lumen. Furthermore, while thecatheters described above are discussed as being suitable for deliveringa guidewire across an aortic valve, it will be understood that thecatheters can also be suitable for delivering guidewires across otherheart valves (e.g., mitral valve, tricuspid valve, etc.). Variousarrangements of the catheter assemblies described herein may also beused to deliver other therapeutic or medical tools within body lumens.For example, targeted and/or aligned delivery of intraluminal cameradevices, surgical tools, prosthetic devices, etc. are contemplated withdescribed alignment assemblies.

Various method steps described above for delivery of the guidewireacross a heart valve (e.g., an aortic valve) of a patient also can beinterchanged to form additional embodiments of the present technology.For example, while the method steps described above are presented in agiven order, alternative embodiments may perform steps in a differentorder. The various embodiments described herein may also be combined toprovide further embodiments.

While various embodiments have been described above, it should beunderstood that they have been presented only as illustrations andexamples of the present technology, and not by way of limitation. Itwill be apparent to persons skilled in the relevant art that variouschanges in form and detail can be made therein without departing fromthe spirit and scope of the present technology. Thus, the breadth andscope of the present technology should not be limited by any of theabove-described embodiments, but should be defined only in accordancewith the appended claims and their equivalents. It will also beunderstood that each feature of each embodiment discussed herein, and ofeach reference cited herein, can be used in combination with thefeatures of any other embodiment. All patents and publications discussedherein are incorporated by reference herein in their entirety.

What is claimed is:
 1. A catheter assembly for crossing a heart valvewith a guidewire, the catheter assembly comprising: a tubular supportstructure adapted to be located at a target location adjacent to theheart valve of a human patient, the tubular support structure includinga proximal segment having a proximal opening at a proximal end, a distalsegment having a distal opening at a distal end, and a plurality ofspaced-apart side ports disposed proximal to the distal opening, whereinthe proximal segment and the distal segment together define therethrougha guidewire lumen configured to slidably receive a first guidewire; anda wire guide slidably disposed within the tubular support structure, thewire guide having a lumen for slidably receiving a second guidewirethrough a proximal guidewire port disposed within a first portion of thewire guide outside of the human patient and transmitting the secondguidewire through a distal guidewire port disposed within a secondportion of the wire guide disposed at the target location adjacent tothe heart valve of a human patient, wherein axial movement of the wireguide relative to the tubular support structure aligns the distalguidewire port of the wire guide with one of the plurality ofspaced-apart side ports, and wherein in a subsequent advancement of thesecond guidewire, the second guidewire exits the aligned side port. 2.The catheter assembly of claim 1, wherein the wire guide furthercomprises a deflector in a portion of the wire guide distally adjacentto the distal guidewire port, wherein the deflector is configured todeflect the second guidewire through the distal guidewire port and thealigned side port at a deflection angle.
 3. The catheter assembly ofclaim 2, wherein each of the plurality of spaced-apart exits portscomprise a partial circumferential slot, and wherein the distalguidewire port of the wire guide is rotationally aligned relative to thepartial circumferential slot such that the deflector deflects the secondguidewire at a selected rotational angle and at the deflection angle. 4.The catheter assembly of claim 3, wherein the selected rotation angle isbetween about 0° and about 90°.
 5. The catheter assembly of claim 1,wherein the wire guide further includes an alignment guide on an outersurface of the first portion, and wherein the alignment guide provides avisual representation of the position of the distal guidewire portrelative to the plurality of spaced-apart side ports on the tubularsupport structure.
 6. The catheter assembly of claim 1, wherein thedistal guidewire port of the wire guide is axially aligned with the oneof the plurality of spaced-apart side ports by pulling or pushing thefirst portion of the wire guide.
 7. The catheter assembly of claim 1,wherein rotational movement of the wire guide relative to the supportstructure alters a rotational angle at which the second guidewire exitsthe aligned side port.
 8. The catheter assembly of claim 1, wherein thesecond guidewire is more flexible than the first guidewire.
 9. Acatheter system for aligning a guidewire relative to an anatomicalfeature in a body lumen of a patient, the system comprising: aguidewire; a tubular component; an alignment assembly disposed at adistal portion of the tubular component and adapted to be located at atarget location within the body lumen of the patient, the alignmentassembly having an outer body and a lumen therethrough, wherein thealignment assembly has a plurality of spaced-apart side ports; a toolguide slidably disposed within the tubular component and the alignmentassembly, the tool guide having an internal lumen for providing a pathfor the guidewire between a proximal opening and a distal openingadjacent the target location within the body lumen of the patient; andan alignment guide disposed on an outer surface of the tool guide at aproximal portion adapted to remain outside the body of the patient,wherein the alignment guide provides a visual representation of theposition of the distal opening relative to the plurality of spaced-apartside ports on the alignment assembly, wherein with the tool guidepositioned such that the distal opening is aligned with one of theplurality of spaced-apart side ports of the alignment assembly, theguidewire extends from the proximal opening of the tool guide, throughthe internal lumen of the tool guide, out of the distal opening of thetool guide, and out of the one of the plurality of spaced-apart sideports.
 10. The system of claim 9, wherein the alignment guide includes aplurality of spaced-apart markers that correspond to the spaced-apartside ports such that axial movement of the tool guide relative to thealignment assembly to a position at a particular marker is indicationthat the distal opening is aligned with the corresponding side port onthe alignment assembly.
 11. The system of claim 9, wherein the alignmentassembly further comprises radiopaque markers associated with each ofthe spaced-apart side ports on the outer body of the alignment assembly.